New Drug Application Accepted for Midazolam Nasal Spray for Treating Patients with Acute Repetitive Seizures

Monday, August 13, 2018

The Food and Drug Administration (FDA) has accepted a new drug application (NDA) filing for midazolam nasal spray (USL261; UCB, Atlanta, GA) for the treatment of persons with epilepsy who experience acute repetitive seizures (ARS). The FDA previously granted orphan drug and fast track status to midazolam nasal spray reflecting that there is a high unmet need for control of intermittent bouts of increased seizure activity. 

In the US, an estimated 44% of patients in the US who are currently being treated for epilepsy still have seizure activity at least once per year. An estimated 150,000 people with epilepsy refractory to treatment also experience ARS, resulting in repeated emergency department visits and hospitalizations. 

The only acute seizure treatment approved for use outside the hospital at present is administered rectally, and while this is effective for many patients and situations, there are social barriers to administration for many patients. If approved, midazolam nasal spray will provide another treatment option for patients with ARS—a treatment that can be taken anytime and anywhere. If approved, midazolam spray will also be the first new medication for ARS in 17 years. 

The application is supported by data from the phase 3 clinical study (ARTEMIS 1) that evaluated the safety and efficacy of midazolam nasal spray in 292 patients. In this study, primary endpoints were met, including termination of seizures within 10 minutes of drug administration and freedom from seizure for at least 6 hours after seizure termination. 

“This is encouraging news for the estimated 150,000 people in the U.S. with refractory epilepsy who experience seizure clusters,” said Mike Davis, Head of U.S. Neurology Patient Value Unit at UCB. “UCB recognizes the challenges these patients and their caregivers face and is committed to working with the FDA as they review our application, in the hopes of addressing an unmet need with a new treatment option, if approved.”

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